Blazer Prime XP cardiac ablation catheters

FDA Premarket Approval P920047 S123

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a design change to the control wire sleeve of the blazer prime htd and blazer prime xp cardiac ablation catheters.

DeviceBlazer Prime XP cardiac ablation catheters
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantBoston Scientific Corp.
Date Received2020-03-30
Decision Date2020-06-04
PMAP920047
SupplementS123
Product CodeLPB 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134

Supplemental Filings

Supplement NumberDateSupplement Type
P920047Original Filing
S123 2020-03-30 Real-time Process
S122 2020-03-12 Normal 180 Day Track No User Fee
S121 2020-01-22 30-day Notice
S120 2020-01-15 30-day Notice
S119 2019-11-22 Real-time Process
S118 2019-10-10 30-day Notice
S117 2019-08-09 30-day Notice
S116 2019-04-12 Real-time Process
S115 2019-04-08 30-day Notice
S114 2019-03-21 30-day Notice
S113 2018-10-30 30-day Notice
S112 2018-10-25 135 Review Track For 30-day Notice
S111 2018-08-24 30-day Notice
S110 2018-06-21 Normal 180 Day Track
S109 2018-06-13 30-day Notice
S108 2018-04-06 135 Review Track For 30-day Notice
S107 2018-01-17 30-day Notice
S106 2017-10-30 30-day Notice
S105 2017-10-02 30-day Notice
S104 2017-09-29 Normal 180 Day Track
S103 2017-09-14 30-day Notice
S102 2017-08-30 30-day Notice
S101 2017-08-04 30-day Notice
S100 2017-07-18 30-day Notice
S099 2017-06-26 30-day Notice
S098 2017-04-27 Real-time Process
S097 2017-04-13 30-day Notice
S096 2017-03-06 30-day Notice
S095 2016-11-22 30-day Notice
S094 2016-07-21 30-day Notice
S093
S092 2016-05-11 Real-time Process
S091 2016-04-15 135 Review Track For 30-day Notice
S090 2016-02-12 30-day Notice
S089 2016-02-12 30-day Notice
S088 2015-11-20 135 Review Track For 30-day Notice
S087 2015-11-19 30-day Notice
S086 2015-09-10 30-day Notice
S085 2015-09-03 30-day Notice
S084 2015-08-18 Special (immediate Track)
S083 2015-06-29 Normal 180 Day Track No User Fee
S082
S081 2015-04-29 30-day Notice
S080 2015-04-29 Special (immediate Track)
S079 2015-04-28 30-day Notice
S078 2015-04-13 30-day Notice
S077 2015-03-12 30-day Notice
S076 2015-01-13 Real-time Process
S075 2014-11-19 30-day Notice
S074 2014-09-22 30-day Notice
S073 2014-06-13 Normal 180 Day Track No User Fee
S072 2014-06-10 Normal 180 Day Track
S071 2014-05-05 Normal 180 Day Track No User Fee
S070 2014-04-30 30-day Notice
S069 2014-03-31 30-day Notice
S068 2014-03-28 30-day Notice
S067 2014-03-04 30-day Notice
S066 2014-02-24 30-day Notice
S065 2014-01-14 30-day Notice
S064 2013-11-21 30-day Notice
S063 2013-10-31 Special (immediate Track)
S062 2013-09-23 30-day Notice
S061 2013-09-19 30-day Notice
S060 2013-09-09 Special (immediate Track)
S059 2013-08-29 30-day Notice
S058 2013-03-25 135 Review Track For 30-day Notice
S057 2013-03-21 30-day Notice
S056 2013-03-04 30-day Notice
S055 2013-01-24 30-day Notice
S054 2012-12-26 30-day Notice
S053 2012-09-03 30-day Notice
S052 2012-04-27 30-day Notice
S051 2012-03-23 30-day Notice
S050 2011-11-07 30-day Notice
S049 2011-09-19 Real-time Process
S048 2011-06-21 Normal 180 Day Track No User Fee
S047 2011-06-09 Real-time Process
S046 2011-03-23 135 Review Track For 30-day Notice
S045 2011-02-28 Normal 180 Day Track No User Fee
S044 2010-10-07 135 Review Track For 30-day Notice
S043 2010-07-27 30-day Notice
S042 2010-05-27 30-day Notice
S041 2010-01-26 30-day Notice
S040 2009-06-03 Normal 180 Day Track No User Fee
S039 2009-04-06 Normal 180 Day Track
S038 2008-09-15 30-day Notice
S037 2007-03-12 Normal 180 Day Track No User Fee
S036 2006-09-21 Real-time Process
S035 2006-08-21 Real-time Process
S034 2006-05-16 30-day Notice
S033
S032
S031 2005-10-13 Normal 180 Day Track No User Fee
S030 2005-09-22 Normal 180 Day Track No User Fee
S029 2005-09-06 30-day Notice
S028 2005-07-18 Normal 180 Day Track
S027 2005-05-19 Real-time Process
S026 2005-01-24 Real-time Process
S025 2004-12-17 30-day Notice
S024 2004-05-26 Real-time Process
S023 2004-04-01 Real-time Process
S022 2003-12-08 30-day Notice
S021 2003-11-03 Normal 180 Day Track No User Fee
S020 2003-10-27 30-day Notice
S019 2003-05-05 Normal 180 Day Track No User Fee
S018 2002-08-28 Normal 180 Day Track
S017 2002-08-07 Real-time Process
S016 2001-11-23 30-day Notice
S015 2001-11-07 Normal 180 Day Track
S014 2001-03-26 30-day Notice
S013 1999-11-05 30-day Notice
S012 1999-03-23 Real-time Process
S011
S010 1998-10-06 Normal 180 Day Track
S009 1997-10-15 Normal 180 Day Track
S008 1997-08-15 Normal 180 Day Track
S007 1997-02-11 Normal 180 Day Track
S006 1996-10-24 Normal 180 Day Track
S005 1995-03-30 Special (immediate Track)
S004 1995-01-12 Normal 180 Day Track
S003 1994-12-05 Normal 180 Day Track
S002 1994-11-21 Normal 180 Day Track
S001 1994-11-17 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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08714729803591 P920047 039

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